1. Field of the Invention
The present invention relates generally to analytical testing devices and methods. More particularly, the invention relates to a point-of-care, screening kit and methods for use by heath care workers, with minimal training, to screen the bodily fluids of individuals for various medical conditions that can, if untreated, later result in severe, medical complications for the individual.
2. Description of the Related Art
Point-of-care testing of bodily fluid specimens, such as urine, saliva, mucus, and sputum, has become well known in today's society as part of a physician's process of diagnosing the medical condition of a patient. Such tests frequently involve the use of various types of test strips (or dipsticks) that have been especially formulated so that one or more portions of them change their color when exposed to an individual's bodily fluids; thereby giving some indication of the medical condition of the individual who supplied the bodily fluid.
These indications arise because the various portions of such strips having been treated with reagents which chemically react with an individual's bodily fluids so as to yield color changes that are indicative of various tested-for, medical conditions. Although such test strips are widely used in many parts of the world, their use in developing countries is often hindered because the prices of these test strips are frequently too expensive and therefore cannot be afforded by the citizens of developing countries or the institutions that provide their medical care.
The consequences of not testing for certain medical conditions, which such test strips could identify, can be devastating. Each year, more than six million pregnant women and newborns die due to complications from pregnancy and childbirth a staggering 99% of these maternal deaths occur in developing countries and many could have been prevented if pre-natal screening had been used to help identify and then treat the underlying medical conditions that yielded these complications.
For example, pre-eclampsia and eclampsia, which alone cause 76,000 maternal and 500,000 infant deaths per year, primarily in developing countries, can, if detected early using existing screening tests, generally be easily treated with steroids and magnesium sulfate. However, at approximately twenty US cents per test strip, currently available test strips for these conditions are too expensive for widespread use in many developing countries.
Additionally, some of the current combinations of reagents and test strips yield only small comparative color changes and therefore are often difficult to accurately interpret by health care workers who have not had extensive training. This situation has limited their use in many developing countries whose health care is workers often have minimal medical training.
Accordingly, there exists a need for low-cost, point-of-care tests for use by heath care workers in developing countries to screen the bodily fluids of individuals, especially pregnant women, for various, medical conditions that can, if untreated, later result in severe, medical complications for the individuals.